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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Biotech Company Settles With SEC Over Failure to Disclose FDA Concerns

The Securities and Exchange Commission (SEC) on Tuesday settled fraud charges against Massachusetts-based biotech company AVEO Pharmaceuticals for $4 million after three former executives allegedly concealed the US Food and Drug Administration’s (FDA) level of concern about approving the cancer drug tivozanib in public statements.

SEC had alleged that AVEO concealed FDA’s concerns with tivozanib in statements to investors by omitting the critical fact that FDA staff had recommended a second clinical trial to address their concerns about patient death rates during the first clinical trial.

When, months later, FDA made public that it had recommended an additional clinical trial, the company’s stock price declined 31 percent. AVEO never conducted an additional trial, and the FDA later denied approval for tivozanib.

Paul Levenson, Director of the SEC’s Boston Regional Office, said: “Companies must be forthcoming about their communications with regulators so investors can make informed investment decisions while knowing what challenges may lay ahead.”

In corporate communications, AVEO and its officers suggested that they intended to satisfy FDA requests by presenting new analyses of the data that had been gathered in the previous clinical trial though they actually went so far as to design a second trial and present trial designs to FDA.

One company executive made public statements during investor conferences suggesting that FDA staff had asked only for an explanation of the survival results, though in reality, FDA staff had recommended a second trial.

The SEC’s complaint charges AVEO and the three former executives with violations of the antifraud provisions of the federal securities laws and various other violations. The settlement is subject to court approval.